AQUILION RXL


Device Classification Name

system, x-ray, tomography, computed

510(k) Number K121553
Device Name AQUILION RXL
Applicant
TOSHIBA MEDICAL SYSTEMS CORPORATION
2441 michelle drive
tustin, 
CA 
92780

Applicant Contact paul biggins
Correspondent
TOSHIBA MEDICAL SYSTEMS CORPORATION
2441 michelle drive
tustin, 
CA 
92780

Correspodent Contact paul biggins
Regulation Number 892.1750
Classification Product Code
JAK  
Date Received 05/25/2012
Decision Date 07/26/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls